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Use of myeloablative Y90-ibritumomab tiuxetan in patients with high-risk CD20+ NHL not eligible for standard ASCT: Five-year results.
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy are designated with a caret symbol (^).
Background: ASCT is the procedure of choice in poor risk NHL, however conditioning regimens is a challenging procedures because safely delivered only in younger and clinically fit patients, thus new approaches are suggested to enhance its applicability. To extend the probability of cure to pts not eligible to standard ASCT from 12/2003 to 7/2007, 60 high-risk CD20+ NHL pts have been included in a phase II study with myeloablative Y90-Ibritumomab Tiuxetan, supported by ASCT. Methods: CD20+ relapsed/refractory or newly diagnosed high-risk NHL adults defined by IPI>3 DLBCL, MCL or transformed BCL, with no upper limit of age not eligible to standard ASCT have been enrolled. Pts were required to collect ≥9 x 106 CD34+cells/kg. Y90-Ibritumomab Tiuxetan (0.8-1.2 mci/kg) was administered after rituximab based HDCT: DHAP x 3, CTX 5-7g/mq followed stem cells collection, Ara-C 12-24 g/mq with 2x106 CD34+ cells/kg support. To hasten hematopoietic recovery, each pt received two stem-cell autograft of 2x106 CD34+ cells/kg on day +7 and of ≥5x106 CD34+ cells/kg on day +14 from RIT. Rationale of the procedure have been published elsewhere (Devizzi: JCO 2008). Results: Characteristics: M/F: 38/22; median age 63 (26-76); median comorbidities: 2 (1-3); Stage III-IV: 54; BM+: 36; newly high-risk NHL: 20; relapsed/refractory DLBC: 5/7; relapsed FCL/MZL 16/6; relapsed MCL: 6; molecular probe: 47. All pts received PCR – autograft. Fifty-two pts reached CR (87%), 3 GPR (5%) 5 PD (8%). Grade 3-4 neutropenia and thrombocytopenia was 37% and 70% with a median duration of 2 and 4 days. Non hemathological toxicity was: 4 pneumonia (6%); 2 mycetoma (3%); 7 CMV/HVZ reactivations (11%); One death occurred one month after transplant for VOD. Four pts developed sMDS/AML. With a median follow-up of 57 months 36 pts are in CCR, 18 pts relapsed, and 43 pts are still alive; the 5-year PFS and OS are 60% and 72% respectively. Conclusions: High dose90Y ibritumomab tiuxetan is an innovative, highly effective and tolerable myeloablative regimen. The incidence of sMDS/AML is similar to that observed with standard CT-based conditioning. Its use is strongly suggested in pts not eligible for standard ASCT.
Abstracts by L. Devizzi:
Safety and activity of the multikinase inhibitor sorafenib in heavily pretreated patients with refractory/relapsed malignant lymphomas: Final results of a phase II study.Meeting: 2011 ASCO Annual Meeting | Abstract No: e13593
High-dose sequential chemotherapy and rituximab (R-HDS) supported by autologous stem cell transplantation (ASCT) in patients (pts) with systemic B-cell lymphoma with CNS involvement (SCNSL) at diagnosis or relapse: Interim analysis of feasibility and activity of a phase II trial.Meeting: 2010 ASCO Annual Meeting | Abstract No: 8081